Testing Enrollment Methods on Participation in Behavioral Economic Interventions for Diabetes Care: A Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Enrollment and participation rates
研究概览
简要总结
The investigator plans to assess enrollment rates among two different enrollment methods, while providing a behavioral economic intervention to enhance the uptake of home-health monitoring devices to lower hemoglobin A1C among patients with uncontrolled diabetes. The study is focusing on enrollment methods since the standard randomized control trial only reaches 15% of the population. The study is seeking to understand the effectiveness of a behavioral intervention, when rolled out in a larger population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults between 18 and 80 years of age
- •Primary care patients at the Division of General Internal Medicine clinics at the University of Pennsylvania
- •Hemoglobin A1c measured within the last 8 weeks greater than 8.0% OR no measured Hemoglobin A1C measured in the last two years
- •A confirmed diabetes diagnosis
- •Planning to stay in area for study duration (6 months)
- •Can understand and communicate fluently in English
排除标准
- •Unable to read and give consent
- •Suffer from an uncontrolled psychiatric disease
研究组 & 干预措施
Opt-in Enrollment
Opt-in enrollment: patient will be sent a recruitment letter, in which they must call the study team to take part in the study. During that call, the study team will schedule the participant for an intake visit.
干预措施: Financial Incentive: Fixed Lottery (Behavioral)
Opt-out enrollment
Opt-out enrollment: patient will be sent a letter communicating to them that they have been enrolled into a research program at their doctor's office. After 10 days, the study team will contact the opt-out participants to schedule an intake visit.
干预措施: Financial Incentive: Fixed Lottery (Behavioral)
结局指标
主要结局
Enrollment and participation rates
时间窗: End of study- 6 months after enrollment
The primary objective is to obtain preliminary evidence regarding whether or not patients opt-into a research study, as opposed to enrolling by default, will affect participation in the program and the effectiveness of the intervention, among high-risk patients. The primary outcome is to measure enrollment rates. The investigators will also measure participation in the program through device usage.
次要结局
- Uptake of Device Usage(End of study- 6 months after enrollment)
研究者
Jaya Aysola
Principal Investigator
University of Pennsylvania